510(k) Report

Devices descending from K013119

2 later devices reach Validate Chem 6 Calibration Verification Test Set Model # 10006 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133550Validate Ferritin Calibration Verification/ Linearity Test KitMaine Standards Company, LLC20141—
+2K142964VALIDATE Anemia Calibration Verification/ Linearity Test KitMaine Standards Company, LLC20150—